NORAV MEDICAL LTD.

Address:4 HAMADA ST.,YOKNEAM Northern,IL

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (MWI) (10)

Premarket Exempt

Yes No

Clear

Norav 1200 Series PC-ECG - 07290110252540 Catalog Number : HASP-SW-K-NEMS-CL-01

Device Description : Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Norav 1200 Series PC-ECG Software Kit with the following Option(s): - ECG Management System NEMS, Cloud Access to NEMS-Q The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 07290110252557 Catalog Number : HASP-SW-K-NEMS-Q-01

Device Description : Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Norav 1200 Series PC-ECG Software Kit with the following Option(s): - ECG Management System NEMS-Q, SQL Base License The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 07290110252564 Catalog Number : HASP-SW-K-NEMS-Q-10-02

Device Description : Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Norav 1200 Series PC-ECG Software Kit with the following Option(s): - ECG Management System NEMS-Q, SQL License for 10 Users The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 07290110252571 Catalog Number : HASP-SW-K-NEMS-Q-250-4

Device Description : Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Norav 1200 Series PC-ECG Software Kit with the following Option(s): - ECG Management System NEMS-Q, SQL License for 250 Users The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 07290110252588 Catalog Number : HASP-SW-K-NEMS-Q-50-03

Device Description : Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Norav 1200 Series PC-ECG Software Kit with the following Option(s): - ECG Management System NEMS-Q, SQL License for 50 Users The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 07290110252595 Catalog Number : HASP-SW-K-NHL7IE-01

Device Description : Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Norav 1200 Series PC-ECG Software Kit with the following Option(s): - HL7 Integration Engine The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 07290110252601 Catalog Number : HASP-SW-K-S2I2D1-01

Device Description : Norav 1200 Series PC-ECG Software Kit (COSMED) with the following Option(s): Norav 1200 Series PC-ECG Software Kit (COSMED) with the following Option(s): - D1 = ECG Management System NEMS - S2 = Advanced Stress-Test ECG - I2 = Resting-ECG Measurement and Advanced Interpretation The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 07290110252618 Catalog Number : HASP-SW-K-H1-01

Device Description : Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Norav 1200 Series PC-ECG Software Kit with the following Option(s): - H1 = Heart Rate Variability Analysis The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 07290110252625 Catalog Number : HASP-SW-K-I1-01

Device Description : Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Norav 1200 Series PC-ECG Software Kit with the following Option(s): - I1 = Resting-ECG Measurement Tool The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

Norav 1200 Series PC-ECG - 07290110252632 Catalog Number : HASP-SW-K-I2-01

Device Description : Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Norav 1200 Series PC-ECG Software Kit with the following Option(s): - I2 = Resting-ECG Measurement and Advanced Interpretation The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).

Device Class : 2

Duns Number: 514773159

Premarket Exempt : Yes

Product Code : MWI

Prescription Use : Yes

Device Count : 1

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